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Archimedes Pharma Launches Lazanda® - the Only Fentanyl Nasal Spray for the Management of Breakthrough Pain in Cancer in the U.S.
Date:10/17/2011

PecFent® (fentanyl pectin nasal spray) in Europe, where it is presently available in six countries.  

"As the first and only treatment option in the U.S. offering fentanyl through nasal administration, Lazanda provides clinically proven pain relief to adult cancer patients suffering from breakthrough pain," noted Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma. "The availability of Lazanda also is an exciting milestone for Archimedes Pharma as it marks our first product launch in the U.S. and represents the expansion of the brand from Europe."

Lazanda will be available through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.

About Lazanda® (fentanyl) nasal spray  Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma's patented drug delivery system, PecSys®.  

Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case the nasal membrane.  Each spray of Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.

The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in patients receiving opioid therapy for background pain, in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity differ
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SOURCE Archimedes Pharma Ltd.
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3. Archimedes Pharma Receives CHMP Positive Opinion for PecFent(R) for the Treatment of Breakthrough Cancer Pain
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